ABC Dental Implant System

Implant, Endosseous, Root-form

Abracadabra Implants Ltd

The following data is part of a premarket notification filed by Abracadabra Implants Ltd with the FDA for Abc Dental Implant System.

Pre-market Notification Details

Device IDK202092
510k NumberK202092
Device Name:ABC Dental Implant System
ClassificationImplant, Endosseous, Root-form
Applicant Abracadabra Implants Ltd 12 Hacharoshet St Or Yehuda,  IL 6037580
ContactDaniel Younisian
CorrespondentVladislav Dvoyris
Blackwell Device Consulating 12 HaHaroshet St. IL 6037580
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-28
Decision Date2021-09-23

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